Menu
Recruiting NCT06780410

A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid

Phase III Interventional Primary Hyperlipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bempedoic Acid Tablet, Placebo.
Who it may be relevant to
Registry conditions: Primary Hyperlipidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins

Overview

This trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.

Interventions

  • Drug Bempedoic Acid Tablet
    Once daily, oral
  • Drug Placebo
    Once daily, oral

Primary outcome measures

  • Percentage change from baseline in LDL-C levels at Week 12 [Time frame: Baseline, Week 12]
Secondary outcome measures (2)
  • Percentage change from baseline in total cholesterol (TC) levels at Week 12 [Time frame: Baseline, Week 12]
  • Adverse events (AEs) and serious adverse events (SAEs) during the study [Time frame: Baseline, Week 13]

Eligibility criteria

Inclusion criteria

  • 1\. 18 years and older, male or female.
  • 2\. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2.
  • 3\. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes.
  • 4\. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process.

Exclusion criteria

  • 1\. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
  • 2\. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening.
  • 3\. History of malignant tumors prior to screening.
  • 4\. History of drug, alcohol, amphetamines, or other drug abuse.
  • 5\. Participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer).
  • 6\. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test.
  • 7\. Any other factors that the investigator believes makes the participant unsuitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Site 01 — Beijing

Identifiers

NCT: NCT06780410 · BDP-HLD-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗